StepOne: An Interactive Smartphone Application to Motivate Smokers to Quit

Sponsor
Ottawa Heart Institute Research Corporation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05799625
Collaborator
(none)
382
1
2
24
15.9

Study Details

Study Description

Brief Summary

Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: StepOne Smartphone Application
N/A

Detailed Description

Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking. The intervention has been designed based by a team of scientist, taking principles of change behaviour into consideration. The application incorporates daily reminders, gamification, and models of habit formation to engage users. It will support participants to reflect on their smoking in a holistic manner through questions and activities.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
382 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
An Interactive Smartphone Application to Motivate Smokers to Quit
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual Care

Eligible smokers randomized to usual care will receive an educational brochure for the University of Ottawa Heart Institute's Ottawa Model for Smoking Cessation (OMSC) Community Program. The brochure will include information about the OMSC Community Program and how to register for it to receive assistance to quit smoking.

Experimental: Intervention

Eligible smokers randomized to the intervention group will be asked to download the StepOne smartphone application onto their smartphone via the Apple Store or Google Play Store. They will be provided with a unique ID and unique code, which will enable them to log into the StepOne smartphone application to begin the 14-day program. Users will interact with the application in the morning and evening; the exact time of the engagement is selected by the participant and ideally at a time that maximizes the likelihood of engaging with the activity. The application incorporates interactive educational material, daily reminders, gamification, and models of habit formation to engage users. As with any other smartphone application, users can turn off notifications if they choose to do so. New content and activities will be shared daily.

Behavioral: StepOne Smartphone Application
This smartphone application provides a 14-day program that delivers the core components of smoking cessation (i.e., counseling, education) and takes advantage of pandemic-accelerated acceptance of virtual care, videoconferencing, remote monitoring, and social networking. The program seeks to move participants from the pre-action stage (not interested in quitting) to the action stage (intention to quit) and incorporates daily reminders, gamification, and models of habit formation to engage users.

Outcome Measures

Primary Outcome Measures

  1. Self-reported readiness to quit [Day 14]

    Collected via survey

  2. Self-reported readiness to quit [Day 45]

    Collected via survey

  3. Self-reported readiness to quit [Day 195]

    Collected via survey

  4. Having made a quit attempt [Day 14]

    Collected via survey

  5. Having made a quit attempt [Day 45]

    Collected via survey

  6. Having made a quit attempt [Day 195]

    Collected via survey

  7. Smoking cessation [Day 45 for participants who report smoking cessation]

    Biochemically verified using an expired carbon monoxide (CO) test

  8. Smoking cessation [Day 195 for participants who report smoking cessation]

    Biochemically verified using an expired carbon monoxide (CO) test

Secondary Outcome Measures

  1. Quit attempts [Day 14, 45, 195]

    Collected via survey

  2. Smoking reduction [Day 14, 45, 195]

    Collected via survey

  3. Point prevalence abstinence [Day 14, 45, 195]

    Collected via survey

  4. Use of behavioural supports (e.g. counselling, quit lines) [Day 14, 45, 195]

    Collected via survey

  5. Use of cessation medication and/or e-cigarettes [Day 14, 45, 195]

    Collected via survey

  6. Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group [Day 14, 45, 195]

    Collected via survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years of age or older.

  • Living in Ontario, Canada.

  • Current smoker who indicates they are not interested in quitting within the next 30-days.

  • Have access to and regularly use a smartphone with internet access.

  • Read, write, speaks English or French.

  • Available and willing to participate in follow-up assessments over the next 6 months.

  • Able to provide consent.

Exclusion Criteria:
  • Planning on quitting smoking within the next 30-days.

  • Cognitively impaired or experiencing acute psychiatric illness that would alter their ability to participate.

  • Institutionalized at a retirement home, nursing home or long-term care facility.

  • Has morbid illness which will prevent completion of 6-month follow-up (e.g., receiving palliative care).

  • Participating in another smoking cessation program

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Ottawa Heart Institute Ottawa Ontario Canada K1Y4W7

Sponsors and Collaborators

  • Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Hassan Mir, MD, The University of Ottawa Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT05799625
Other Study ID Numbers:
  • 20220696-01H
First Posted:
Apr 5, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 5, 2023